FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/12/098508 [Registered on: 05/12/2025] Trial Registered Prospectively
Last Modified On: 05/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Single Arm Study 
Public Title of Study   Studying the Effectiveness of a Herbal Unani Medicine for Chronic Pharyngitis. 
Scientific Title of Study   Evaluation of the efficacy of polyherbal Unani formulations in the management of Waram-i-Halq Muzmin (chronic pharyngitis): An open-label, single-arm study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nazar Hasan 
Designation  PG Scholar 
Affiliation  State Unani Medical College and Hospital 
Address  Department of Amraze Ain Uzn Anf Halq wa Asnan State Unani Medical College and Hospital Himmatganj Prayagraj
Old GT Road Himmatganj Prayagraj 211016
Allahabad
UTTAR PRADESH
211016
India 
Phone  8299228481  
Fax    
Email  drnhkhan92@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Usamah Ahmad 
Designation  Reader 
Affiliation  State Unani Medical College and Hospital 
Address  Department of Amraze Ain Uzn Anf Halq wa Asnan State Unani Medical College and Hospital Himmatganj Prayagraj
Old GT Road Himmatganj Prayagraj 211016
Allahabad
UTTAR PRADESH
211016
India 
Phone  9415639877  
Fax    
Email  arogyaherbal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nazar Hasan 
Designation  PG Scholar 
Affiliation  State Unani Medical College and Hospital 
Address  Department of Amraze Ain Uzn Anf Halq wa Asnan State Unani Medical College and Hospital Himmatganj Prayagraj
Old GT Road Himmatganj Prayagraj 211016
Allahabad
UTTAR PRADESH
211016
India 
Phone  8299228481  
Fax    
Email  drnhkhan92@gmail.com  
 
Source of Monetary or Material Support  
State Unani Medical College and Hospital Prayagraj India 211016 
 
Primary Sponsor  
Name  State Unani Medical College and Hospital  
Address  Old GT Road Himmatganj Prayagraj 211016 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Nazar Hasan  State Unani Medical College and Hospital  Old GT Road Himmatganj Prayagraj Department of Amraze Ain Uzn Anf Halq wa Asnan
Allahabad
UTTAR PRADESH 		 8299228481

drnhkhan92@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J312||Chronic pharyngitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Joshanda of Behdana Unnab Sapistan with Sharbat Toot Siyah  sixty milliliter Joshanda with two tola Sharbat Toot Siyah twice daily for 45 days. 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Participants aged eighteen years to sixty five years of either gender
Clinically diagnosed cases of waram i halq muzmin
Presence of symptoms such as sore throat dry throat or pharyngeal itching along with clinical signs including pharyngeal mucosal edema mucosal congestion or stasis of secretions persisting for more than three weeks
Mild to moderate disease severity based on clinical assessment with absolute eosinophil count less than five thousand per millimeter cube
Participants willing to provide written informed consent and comply with the study protocol for the entire study duration 
 
ExclusionCriteria 
Details  Pregnant and lactating women
Known cases of renal hepatic or cardiac ailments or diabetes mellitus
Participants who have taken antibiotics or other medications for chronic pharyngitis within the past fifteen days
Chronic pharyngitis with complications as assessed clinically or radiologically
Participants who do not provide written informed consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in AEC   At Baseline
At 30 days
At 45 day 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of Quality of Life using a validated questionnaire a disease specific QoL scale  At Baseline
At 45 days 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   27/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drnhkhan92@gmail.com].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 31-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is an open-label, single-arm interventional clinical study to evaluate the efficacy and safety of a polyherbal Unani formulation in 44 participants recruited from a single centre in India. The primary endpoint is change in Absolute Eosinophil Count (AEC) and improvement in subjective symptoms including hoarseness of voice, dry cough, dysphagia, and throat irritation, assessed at baseline and day 45. The secondary endpoint is quality-of-life improvement measured using a validated questionnaire at baseline and day 45. 
Close